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New criteria for vendors are meant to ease burdens and ultimately pass cost-savings down to the hospitals and systems that buy electronic health record software, Donald Rucker says.

The Office of the National Coordinator for Health IT’s plans to change the ONC Health IT Certification Program has sparked some important questions. Wouldn’t allowing vendors to now simply say they’re in compliance, rather than prove it in an ONC-Authorized Testing Laboratory, pave the way for EHR vendors to essentially flout the rules? And what’s to prevent more certification problems such as the eClinicalWorks $155 million settlement?

But National Coordinator Donald Rucker, MD, said ONC wasn’t sacrificing any of its regulatory oversight but was simply doing what it could to reduce the hoop-jumping required of vendors so they could better allocate their resources to more usable and interoperable products.

“What we’re trying to do here is make things as smooth as possible in the regulatory process,” Rucker said Thursday during a call with reporters. “We’re not changing the certification requirements, per se. We’re doing a little bit of streamlining on the process. So that will hopefully, in part, reduce vendors costs – and in a market economy over time some of those savings come down to providers.”

With the new rules, compliance requirements remain the same as ever, according to ONC. But now, rather than vendors having to put in the work to demonstrate, for instance, a relatively simple functionality such as CPOE for medications to a test lab, they can simply affirm that their product does that task, while focusing more of their time and energy on innovation.

But didn’t the eClinicalWorks case show that sometimes a verbal promise isn’t good enough? And that sometimes more stringent testing – showing, not telling – is necessary?

Rucker doesn’t think so.

“The reality is that these are very public products,” he said. “They have user bases who immediately know if something is working or not working. If a CPOE doesn’t go through, these things are known almost instantaneously. So the vast bulk of the oversight is provided by those using the product. This has to be looked at in the broader context of use. That’s where the data was coming from in prior enforcement actions.”

Actually, he said the eClinicalWorks case is “a perfect example that what we have in place in fact does work.”

The discrepancies with eCW’s products were first “noted by end-users,” he said. That case was ultimately investigated further thanks to reactive surveillance – not the randomized surveillance that would be reduced as part of these new rules.

ONC still fully intends to take an aggressive approach to reactive surveillance. In fact, just this past month it updated its Health IT Feedback Form, making it easier and more intuitive for providers to approach the agency with complaints or concerns about their products.

“Our experience is that people will report if there are issues with their product,” said Rucker.

He emphasized that all certification criteria are still in place and enforceable. And he said he didn’t see much changing for ONC-Authorized Certification Bodies and ONC-Authorized Testing Laboratories.

The self-declarable criteria are all relatively basic functionalities, after all. Those that require conformance testing to interoperability standards are still being affirmed by ONC-ATLs.

“There are a lot of things that are still being tested,” he said. And even for those criteria that are now self-declarable, “you still have to know how to solve the equation. It doesn’t change what you have to learn.”

In other words, even with the new rules, when a product is certified, the vendor is attesting that it does what it’s supposed to do. If that’s later found out not to be the case, either by an ACB or through subsequent reactive surveillance, ONC will take action – correcting where there is a non-conformity or even decertifying a given product.

The bulk of certified technologies “do exactly what is asked of them from the certification criteria,” said Rucker. “Building medical software is a highly iterative process. And there are many inputs on this. Because these foundations tend to be so heavily used – minute in, minute out – things become obvious relatively rapidly.”

The aim here, said Rucker, is to “increase the operational efficiency of the vendors to the extent that we can. Because those (testing) costs are all eventually, sooner or later, borne by the providers purchasing the products.”

KEY FINDINGS:

The September Kaiser Health Tracking Poll, fielded largely prior to the most recent Republican effort to repeal the 2010 health care law, finds three-fourths of the public saying it is important for Congress to work on reauthorizing funding for the State Children’s Health Insurance Program (CHIP), which provides health care coverage for uninsured children. Democrats prioritize reauthorizing CHIP funding and stabilizing the ACA marketplaces, with at least eight in ten saying each is an important priority for Congress to work on now. These are also the highest-ranking priorities among independents, with about seven in ten saying the same about both reauthorizing CHIP and stabilizing the marketplaces. Republicans, on the other hand, are more likely to prioritize continuing efforts to repeal and replace the ACA, with 71 percent saying that is important for Congress to do now.

In general, Republicans are more likely to want Republicans in Congress to focus on repeal efforts than on improving the way the Affordable Care Act (ACA) is working (66 percent v. 28 percent), while most Democrats want Democrats in Congress to focus on improving the way the ACA is working (52 percent) rather than trying to pass a national health care plan (43 percent). A majority of independents want Democrats and Republicans in Congress to focus their efforts on improving the way the ACA is working rather than focusing on either a national health care plan or repealing the ACA.

Half of the public thinks the ACA marketplaces are “collapsing.” One proposed step Congress could take to stabilize the markets and control costs for people who purchase their own plans is to guarantee cost-sharing reduction (CSR) payments to insurance companies. The Trump Administration has said they may stop making these payments, which has led to insurance companies saying they may raise premiums or stop participating in the marketplaces. Two-thirds of the public – including majorities of Democrats and independents – say Congress should guarantee the CSR payments in order to help stabilize the insurance market while about three in ten of the overall public and about half of Republicans (53 percent) say these payments constitute bailouts to the insurance companies and should be stopped. Overall, about seven in ten Americans are not confident that President Trump and Congress will be able to work together to make improvements to the ACA marketplaces.

Overall views of the ACA are once again divided, with 46 percent expressing a favorable view and 44 percent expressing an unfavorable view. While overall favorability increased over the past year, this month finds a return to a divided public that characterizes most of the last seven years.

This month’s Kaiser Health Tracking Poll examines public support for a variety of competing health care policies aimed at improving or replacing the 2010 health care law, including plans to allow people to “buy in” to Medicaid or Medicare.

After the Senate failed to pass a bill to repeal parts of the 2010 Affordable Care Act (ACA) in late-July, some lawmakers have turned their attention to various competing national health policy issues, including efforts to stabilize the ACA marketplaces, proposals to create a single-payer health care system, and the reauthorization of funding for the State Children’s Health Insurance Program (CHIP), while some have continued to focus on repealing and replacing the ACA. This month’s Kaiser Health Tracking Poll examines how Americans are prioritizing the competing health care issues as well as their attitudes toward possible changes to the current health care system.

What Should Congress Work on Now?

Congress has a number of competing priorities for the month of September, and when asked about several of the issues they may address this month, a large majority of the public see reauthorizing funding for CHIP and passing legislation to stabilize the ACA marketplaces as important priorities for Congress to work on now. Specifically, three-fourths of the public (75 percent) say it is “extremely” or “very” important for Congress to work on reauthorizing funding for CHIP, the program which provides health care coverage for uninsured children. This is followed by seven in ten (69 percent) who say the same about passing legislation to stabilize the ACA marketplaces in order to minimize premium increases and encourage more insurers to offer health plans. Fewer, but still about half, say it is “extremely” or “very” important for Congress to work on reforming the tax code, which may cut taxes for some individuals (49 percent), or work on continuing efforts to repeal and replace the 2010 health care law (47 percent).

At a high level, the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 accomplished something miraculous: the vast majority of U.S. hospitals and physicians are now active users of electronic health record (EHR) systems. No other sector of the U.S. economy of similar size (one sixth of the gross domestic product) and complexity (more than 5000 hospitals and more than 500,000 physicians) has undergone such rapid computerization.

Along the way, however, we lost the hearts and minds of clinicians. We overwhelmed them with confusing layers of regulations. We tried to drive cultural change with legislation. We expected interoperability without first building the enabling tools. In a sense, we gave clinicians suboptimal cars, didn’t build roads, and then blamed them for not driving. Burdensome requirements imposed costs on providers and vendors without offering sustained benefit. These deficiencies were manifested in five key areas: usability, workflow, innovation, interoperability, and patient engagement.

The Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) set ambitious requirements for “meaningful use” of health information technology (IT) to ensure that Medicare and Medicaid would get value from their large investment on a fixed timeline. But in the absence of business and clinical drivers for change (HITECH predated the Affordable Care Act by more than a year), meaningful use came to be used as a de facto vehicle for transforming health care delivery — a purpose for which, as a technology investment program, it was not adequate.

This approach led to complex requirements that stressed processes more than outcomes, telling providers not only what they should do with their EHRs but also how they should use them. For example, quality measurement added data collection requirements that had a substantial negative effect on usability with little return; performance was not connected with payments. Providers bristled at externally imposed process-oriented requirements that dictated their user experience without a corresponding change in reimbursement policies or clinical best practices.

This challenging situation became untenable for daily practice workflow when meaningful use was added to other disconnected regulatory requirements, including the International Classification of Diseases, 10th Revision (ICD-10), the Omnibus Rule of the Health Information Portability and Accountability Act (HIPAA), and new payment models from commercial and government accountable care organization (ACO) programs.

Soon physicians were expected to provide high-quality and empathic care in a 12-minute visit while weaning themselves from paper based workflows, entering the numerous structured data elements required for meaningful use, rolling out new HIPAA privacy notices, implementing security protections for new electronic data, learning and incorporating new ICD-10 billing codes, and convincing their patients to use patient portals and secure e-mail, all while avoiding safety and malpractice issues. Instead of being a gift horse that reduced clinician burden, the EHR became an expensive Trojan horse loaded with an array of new regulatory requirements.

It wasn’t just the providers who suddenly faced an avalanche of requirements. EHR vendors seeking to innovate had to meet complex certification requirements, administered by ONC-authorized testing companies, that imposed not only direct costs, but large opportunity costs as well. Development resources had to be diverted to programming of complex certification requirements to meet the technical, functional, and workflow requirements of meaningful use, which left little available capacity for innovation and product development based on user experience.

Over time, providers and vendors began to perceive meaningful use as yet another check-the-box compliance program. Furthermore, meaningful use set unrealistic expectations for interoperability. Though it did not specify a nationwide patient matching strategy, create a nationwide directory of provider electronic addresses, forge a single set of consent or privacy guidelines, or define governance for deciding who could exchange what for various purposes, it set requirements with the assumption that interoperability could somehow skip over such essentials.

Instead of recognizing the work that needed to be done on these foundational items, some policymakers invented the myth of “information blocking” as the root cause for lack of data flow. Our 50-plus combined years in the health IT industry have taught us that when technology, policy, and business needs are aligned, data flow.

As health care organizations have moved to value-based purchasing, they are finding that data sharing is a business imperative. The needs of care management are now creating genuine demand for interoperability services, such as “pushing” data to support referrals and transitions and “pulling” data for unscheduled visits such as emergency care. The meaningful use program did not stress any outcome from data sharing. Instead, it required a specific technology and set a process goal: adopt secure e-mail and count the number of messages sent. Many organizations set up “dead letter boxes” to send secure e-mail and comply with the requirement without ensuring that any clinical benefit was provided.

Today, the private sector is meeting burgeoning demand for interoperability with nationwide, standards-based networks that solve key issues such as patient matching, provider directories, uniform consent and privacy policies, data governance, common contracts, and well-defined business cases. Such networks include Carequality, CommonWell, DirectTrust, Epic’s CareEverywhere, and Surescripts at the national level, as well as regionally focused health information exchange networks such as those in Indiana, Maine, Maryland, and Massachusetts.

They also now include record sharing with government entities such as the Department of Defense (DOD), the Department of Veterans Affairs (VA), and the Social Security Administration (SSA). Standards obviously play a key role in interoperability, and meaningful use has done much to accelerate the implementation of vocabulary standards such as SNOMED-CT (Systematized Nomenclature of Medicine — Clinical Terms), LOINC (Logical Observation Identifiers Names and Codes), and RxNorm, which have been widely adopted. Emerging open standards such as FHIR (Fast Healthcare Interoperability Resources), based on modern Internet conventions, are being embraced by the industry and are attracting companies and developers from outside health care to build innovative business models and technology platforms that are already reshaping the industry.

In terms of patient engagement, early attempts such as Blue Button (allowing patients to download text files of parts of their records) were well-intended efforts that ultimately did little to engage patients. One success of meaningful use was creating an imperative, and mechanisms, for giving patients access to their medical records, albeit through unwieldy, EHR-tethered patient portals.

If we want patients to be engaged to help reduce the burden of care coordination, care plan tracking, and communication, we need modern tools that enable patients to interact with their providers using devices and workflows that are already part of their daily lives. Many companies are now offering such tools. HITECH has played an invaluable role in accelerating the adoption of EHRs throughout the country.

We believe that now is the time to step back and recalibrate the role of the federal government on the basis of lessons learned. First, requirements related to meaningful use and the MeritBased Incentive Payment System (MIPS) introduced by CMS could be dramatically simplified to focus on interoperability and a streamlined set of outcome-oriented quality measures.

Second, EHR certification could focus exclusively on interoperability capabilities by setting up a public test server and reporting on EHR vendors’ success in reading and writing medical records on it.

Third, interoperability could be encouraged by market action rather than by regulation. The ONC, CMS, DOD, VA, SSA, and other federal agencies could actively encourage private-sector networks to connect with each other using open industry standards, much as wireless and automated-teller networks have done.

Finally, we could offer incentives for the adoption of open industry application programming interface (API) standards, such as FHIR, for provider– patient, provider–provider, provider–payer, and payer–patient interactions. The HITECH era was an important catalyst for EHR adoption, and the industry benefited from government intervention. If the post-HITECH era can return control of the agenda to customers, developers, and multi-stakeholder collaborations, we should be able to recapture the hearts and minds of our clinicians.

A hospital administrator recently talked to us about an issue that is all too common for patients: missed medical appointments. The story was about a woman named Mary (a pseudonym), a patient with a painful chronic condition who continually failed to keep her regular appointments. In an effort to better understand the problem at hand, the administrator tried to put herself in Mary’s shoes, and asked about her experience: Was there an issue with transportation? Did she need other appointment reminders aside from the paper letter mailed to her home and the standard phone call?

Slowly, Mary began to reveal the reasons why she never made it to her appointments. Her journey to the hospital was quite daunting. For starters, her painful physical condition required her to arrange door-to-door assistance and special transportation. Everyone involved had to be on the same page for her to make it to her appointment on time, and coordinating the logistics was onerous and stressful.

Mary faced an additional set of challenges once she got to the hospital. Mary sought care at a large academic medical center with multiple entrances and towers; at times she was expected to travel long distances due to the sheer size of the facility. She worried that she wouldn’t be able to find someone to push her in a wheelchair, or that she might get lost. Simply thinking about the various hurdles of this journey made Mary anxious to the point of talking herself out of going at all.

Each year approximately 3.6 million people miss or put off medical appointments due to transportation issues, leading to annual costs for health care providers in the billions of dollars. Missed medical appointments, or “no-shows,” often create several operational challenges as well, from difficulties rescheduling clinical staff to interference with patient care and treatment. While the consequences of missed appointments have been widely studied, the specific reasons patients fail to show up are not always as clear. But until we understand these reasons, we won’t be able to solve the problems. This is where paying closer attention to the entire patient experience — from what happens before people get to the hospital to what happens after they leave — can help.

Many leading hospitals are starting to focus more on understanding the patient experience to solve these kinds of problems, as well as to improve overall patient experience and to lower costs. Yet it’s not always easy to get key stakeholders to consider nonclinical aspects of this type of work.

One of the most promising approaches for understanding patients’ experiences has been design thinking, a creative, human-centered problem-solving approach that leverages empathy, collective idea generation, rapid prototyping, and continuous testing to tackle complex challenges. Unlike traditional approaches to problem solving, design thinkers take great efforts to understand patients and their experiences before coming up with solutions. This thorough understanding of patients (for example, those who regularly miss appointments) is what guides the rest of the process. And because design thinking involves continuously testing and refining ideas, feedback is sought early and often, especially from patients.

Design thinking has already taken hold in health care, leading to the development of new products and the improved design of spaces. Yet it remains underused in addressing other important challenges, such as patient transportation, communication issues between clinicians and patients, and differential treatment of patients due to implicit bias, to name just a few. If more leaders embrace design thinking, they can leverage a deeper understanding of patients to solve such problems, achieving better clinical outcomes, improved patient experience, and lower costs along the way.

Designing a Patient-Centered Experience

How might design thinking be applied to the persistent and costly problem of no-shows? In Mary’s case, she couldn’t explain her concerns through the standard patient experience survey, which is initiated after an appointment and which comprises general questions focused on the medical visit. Were it not for the hospital administrator’s initiative to ask Mary what was going on, her concerns may have gone both unnoticed and unaddressed.

This tailored, human-centered approach of problem solving is the foundation of design thinking. Hospitals versed in design thinking would identify this general challenge and then assign a team or task force (ideally a multidisciplinary one) to spend weeks or even a few months studying the patients it affects. The team would use qualitative research methods, such as surveys, focus groups, and observations, to better understand people’s experiences. They would seek out patterns and aim to define the real problem at hand. For instance, a team investigating several no-shows would quickly see that many cases do not necessarily involve a patient’s forgetfulness or time management. They’d find that the issue faced by patients like Mary is often more socioemotional than organizational.

After this phase, the team would brainstorm possible solutions, and then begin rapid prototyping to test them. Depending on the proposed solution, a prototype could be anything from a physical mock-up to a skit or a flowchart. For example, if the team wanted to design a screening process to identify individuals with transport-related concerns, they could design a simple computerized simulation that illustrates how that process might look and feel to both patients and staff. Once created, this prototype would be tested by relevant stakeholders and perhaps even outside parties to collect critical feedback. Often, the feedback indicates when or how to modify solutions, or whether to go back and gather more information. The result is a solution focused on what will most help the patient.

Addressing a Broader Spectrum of Patient Challenges

There are already a few promising examples of design thinking being used to create a better experience for patients. For instance, the department of obstetrics and gynecology at Mayo Clinic used design thinking to reimagine prenatal care. They wanted to better meet the expectations and needs of expectant mothers, who desired a greater emphasis on the emotional experience of pregnancy, rather than just the clinical side of it. Through interviews with and observations of local expectant mothers, the design thinking team learned that it was extremely important for these women to have a sense of community. So the department created online care communities, facilitated by nurses and other pregnancy advisers. The result was an overall improvement in how prepared and empowered these expectant mothers felt.

At Johns Hopkins Hospital, elements of the design thinking process are embedded in the hospital’s approach to improving care. To provide the human touch that is necessary to improve the patient experience, we have a team of coaches, trained in the importance of empathy in clinical settings, that teaches caregivers how to partner with patients and be more present with them. For instance, coaches teach clinical staff how to reject a patient’s request when necessary (for example, when asked for more pain medication) while still projecting a caring message. On the patient side, we have a team of advocates that visit people facing unusually difficult circumstances, such as having to endure a long wait without food or water before surgery. Advocates offer support by connecting them to the right staff members or simply by listening to their concerns. Advocates support patients and encourage them to be engaged in their own care. This often involves identifying what matters to them and their loved ones and, above all, recognizing the patient as a whole person, not as a condition or an illness.

Design thinking can be used to address challenges in a variety of domains related to the patient experience. Consider reimagining the emergency-room waiting experience. Because care is prioritized based on the severity of a patient’s condition, wait times are difficult to predict. Patients and their families often spend hours waiting to be seen and treated. Design thinking may uncover new ways of helping patients feel comfortable and safe during such long waits. An approach that starts with investigating the patients’ perspectives, including their greatest pain points, may give administrators ideas for how to make the emergency room experience more bearable.

It’s every health care leader’s mission to improve patient experiences. Design thinking is a useful process for doing so, as it requires decision makers to empathize with patients, think creatively, prototype, and continually test solutions to these problems. The answers to problems like no-shows start with getting to know Mary and patients like her.

Sharon H. Kim, Ph.D., is an assistant professor of management for the Johns Hopkins Carey Business School and associate faculty at Armstrong Institute of Patient Safety and Quality. Her research explores creativity in the workplace, and she teaches design thinking for health care leaders.

Christopher G. Myers is an assistant professor at the Johns Hopkins University Carey Business School and Armstrong Institute for Patient Safety & Quality. His research explores organizing processes that support individual learning, development, and innovation in dynamic work environments.

Lisa Allen, Ph.D., is the Chief Patient Experience Officer for Johns Hopkins Medicine. In this role she has oversight and responsibility for enhancing and continually improving the overall experience of patients and families by coaching, utilization of best practices, transparency, reporting, and system collaboration.